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Please see the corresponding US participant summary for any statistics not represented in this supplement.

M E D I C A L L A B O R A T O R Y

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PARTICIPANT SUMMARY

2 • 0 • 1 • 5

International Data Supplement MLE-M3

Total Commitment to Education and Service

Provided by ACP, Inc.

2 /2015 MLE-M3 International Data Supplement .

Table of Contents

Evaluation Criteria .............................................................................................................................................. 4

Hematology Hematology with 5-part Automated Differential (CL Samples – Module 223) ..................................................... 5

White Blood Cell Count ....................................................................................................................................... 5

Red Blood Cell Count ......................................................................................................................................... 6

Hemoglobin ......................................................................................................................................................... 7

Hematocrit .......................................................................................................................................................... 8

Platelet Count ..................................................................................................................................................... 9

Automated Differential ...................................................................................................................................... 10

Blood Bank ABO Group ............................................................................................................................................................. 15

Rh Factor (D Type) ................................................................................................................................................. 15

Unexpected Antibody Detection ........................................................................................................................... 16

Antibody Identification .......................................................................................................................................... 16

Compatibility Testing............................................................................................................................................. 17

Coagulation Prothrombin Time .................................................................................................................................................. 18

International Normalized Ratio (INR) ................................................................................................................ 21

Activated Partial Thromboplastin Time ................................................................................................................ 24

Fibrinogen .............................................................................................................................................................. 26

Urinalysis

Urinalysis Dipstick ................................................................................................................................................. 27

Specific Gravity ................................................................................................................................................. 27

pH ..................................................................................................................................................................... 28

Protein .............................................................................................................................................................. 29

Glucose ............................................................................................................................................................. 30

Ketones ............................................................................................................................................................. 31

Bilirubin ............................................................................................................................................................. 32

Urobilinogen ...................................................................................................................................................... 33

Blood or Hemoglobin ........................................................................................................................................ 34

Leukocyte Esterase .......................................................................................................................................... 35

Nitrite ................................................................................................................................................................ 36

Microalbumin (Dipstick Only) ............................................................................................................................ 37

Urine hcG ................................................................................................................................................................ 37

Microbiology

Antimicrobial Susceptibility Testing .................................................................................................................... 38

Parasitology (PA Specimens) ............................................................................................................................... 40

Parasitology (FP Specimens) ................................................................................................................................ 42

2015 MLE-M3 International Data Supplement/ 3

Table of Contents (cont’d) Immunology

Antinuclear Antibody ..............................................................................................................................................47

Qualitative ..........................................................................................................................................................47

Quantitative........................................................................................................................................................48

Anti-dsDNA ..............................................................................................................................................................49

Anti-RNP ..................................................................................................................................................................49

Anti-RNP/Sm ...........................................................................................................................................................50

Anti-SSA ..................................................................................................................................................................50

Anti-SSB ..................................................................................................................................................................51

Anti-SSA/SSB ..........................................................................................................................................................51

Anti-Sm ....................................................................................................................................................................52

Rubella .....................................................................................................................................................................53

Qualitative ..........................................................................................................................................................53

Quantitative........................................................................................................................................................54

Syphilis Serology ....................................................................................................................................................55

VDRL Slide ........................................................................................................................................................55

VDRL Slide (Titer) ..............................................................................................................................................56

MHA-TP .............................................................................................................................................................57

TPA ....................................................................................................................................................................58

RPR ...................................................................................................................................................................59

RPR (Titer).........................................................................................................................................................60

Viral Markers ...........................................................................................................................................................62

Anti-HBc (IgM) ...................................................................................................................................................62

Anti-HBc (Total/IgG) ..........................................................................................................................................63

Anti-HIV .............................................................................................................................................................64

Anti-HAV (IgM) ...................................................................................................................................................66

Anti-HAV (Total/IgG) ..........................................................................................................................................67

HBeAg ...............................................................................................................................................................68

Anti-HBs ............................................................................................................................................................69

HBsAg ...............................................................................................................................................................70

Anti-HCV ............................................................................................................................................................71

Toxoplasma gondii .................................................................................................................................................72

Qualitative (IgG) .................................................................................................................................................72

Quantitative (IgG) ..............................................................................................................................................72

Qualitative (IgM) ................................................................................................................................................73

Quantitative (IgM) ..............................................................................................................................................73

Cytomegalovirus (CMV) .........................................................................................................................................74

Qualitative (IgG) .................................................................................................................................................74

Quantitative (IgG) ..............................................................................................................................................74

Qualitative (IgM) ................................................................................................................................................75

Quantitative (IgM) ..............................................................................................................................................75

Chemistry

CK-MB ......................................................................................................................................................................76


EVALUATION CRITERIA The evaluation criteria used in the MLE Program is in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) federal requirements for proficiency testing. The criteria are included below.

Qualitative For qualitative procedures, evaluation is based on participant or referee consensus. A minimum percentage of participants must receive a passing score or the challenge is not evaluated due to lack of consensus. These percentages are listed below. Antimicrobial Susceptibility Testing 80% Consensus

Antinuclear Antibody 80% Consensus

Blood Bank 95% Consensus

Cytomegalovirus 80% Consensus

Microalbumin (Semi-Quantitative) 80% Consensus

Parasite Identification 80% Consensus

Rubella 80% Consensus

Syphilis Serology 80% Consensus

Toxoplasma 80% Consensus

Urine Dipstick 80% Consensus

Urine hCG 80% Consensus

Viral Markers 80% Consensus

Quantitative For quantitative procedures, a mean and standard deviation (SD) are calculated for each peer group consisting of 10 or more laboratories. Acceptable performance is

established based on a target value the intervals below. An explanation on how to calculate the range of acceptability based upon these limits is also provided in your MLE Program Guide on page 37 under the heading "Acceptable Ranges for Quantitative Results."

Activated Partial Thromboplastin Time 15%

Automated Differential 3 SD

CK-MB (U/L) 3 SD

Cytomegalovirus 2 SD

Fibrinogen 20%

Hematocrit 6%

Hemoglobin 7%

International Normalized Ratio (INR) 20%

Platelet Count 25%

Prothrombin Time 15%

Red Blood Cell Count 6%

Rubella 3 SD

Specific Gravity 0.010

Toxoplasma 2 SD

White Blood Cell Count 15%


HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x K/uL)

Specimen CL-11 Specimen CL-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 78 2.98 0.36 12.2 3.1 2.5 - 3.5 78 7.72 0.73 9.4 8.0 6.5 - 8.9 All Abbott Cell-Dyn Instruments 59 3.16 0.13 4.2 3.2 2.6 - 3.7 60 8.05 0.32 4.0 8.1 6.8 - 9.3 Abbott Cell-Dyn Ruby 44 3.16 0.13 4.2 3.2 2.6 - 3.7 44 8.10 0.24 2.9 8.1 6.8 - 9.4 Orphee Mythic 22 16 2.33 0.11 4.8 2.3 1.9 - 2.7 16 6.42 0.22 3.4 6.4 5.4 - 7.4

Specimen CL-13 Specimen CL-14 All Method 78 24.67 2.12 8.6 25.4 20.9 - 28.4 78 3.11 0.46 14.9 3.2 2.6 - 3.6 All Abbott Cell-Dyn Instruments 59 25.64 1.06 4.1 25.7 21.7 - 29.5 58 3.30 0.18 5.5 3.3 2.8 - 3.8 Abbott Cell-Dyn Ruby 43 25.79 0.61 2.4 25.9 21.9 - 29.7 43 3.36 0.18 5.5 3.4 2.8 - 3.9 Orphee Mythic 22 17 21.16 0.81 3.8 21.2 17.9 - 24.4 16 2.29 0.09 4.0 2.3 1.9 - 2.7

Specimen CL-15

All Method 79 7.74 0.74 9.6 8.0 6.5 - 8.9

All Abbott Cell-Dyn Instruments 60 8.10 0.28 3.4 8.1 6.8 - 9.4

Abbott Cell-Dyn Ruby 44 8.14 0.27 3.3 8.1 6.9 - 9.4

Orphee Mythic 22 17 6.41 0.15 2.3 6.4 5.4 - 7.4


HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x M/uL)




Specimen CL-15

All Method 79 4.540 0.154 3.4 4.58 4.26 - 4.82



Orphee Mythic 22 17 4.324 0.092 2.1 4.34 4.06 - 4.59


HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)




Specimen CL-15

All Method 79 13.21 0.73 5.5 13.5 12.2 - 14.2



Orphee Mythic 22 17 11.89 0.21 1.8 11.9 11.0 - 12.8


HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)




Specimen CL-15

All Method 78 38.60 1.71 4.4 38.4 36.2 - 41.0



Orphee Mythic 22 17 39.23 1.28 3.3 39.3 36.8 - 41.6


HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x K/uL)


All Method 75 76.8 8.7 11.3 75 57 - 97 78 254.4 16.0 6.3 253 190 - 318 All Abbott Cell-Dyn Instruments 60 73.4 4.9 6.7 73 55 - 92 60 252.3 15.5 6.1 252 189 - 316 Abbott Cell-Dyn Ruby 44 73.3 5.0 6.9 74 54 - 92 44 254.0 15.1 5.9 253 190 - 318 Orphee Mythic 22 16 95.7 10.5 11.0 93 71 - 120 16 264.8 13.0 4.9 266 198 - 331

Specimen CL-13 Specimen CL-14

All Method 77 578.7 37.5 6.5 581 434 - 724 77 77.7 10.8 13.9 75 58 - 98 All Abbott Cell-Dyn Instruments 58 590.5 30.8 5.2 589 442 - 739 59 73.1 5.6 7.6 73 54 - 92 Abbott Cell-Dyn Ruby 42 595.1 27.0 4.5 594 446 - 744 43 72.3 4.9 6.8 71 54 - 91 Orphee Mythic 22 17 546.9 31.4 5.7 540 410 - 684 16 93.9 10.4 11.0 93 70 - 118

Specimen CL-15

All Method 78 254.1 17.7 7.0 254 190 - 318

All Abbott Cell-Dyn Instruments 60 252.0 15.0 5.9 253 188 - 315

Abbott Cell-Dyn Ruby 44 254.2 13.9 5.5 254 190 - 318

Orphee Mythic 22 16 265.3 21.6 8.1 265 198 - 332


HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)




Specimen CL-15

All Method 77 62.34 1.34 2.2 62.4 58.3 - 66.4



Orphee Mythic 22 17 60.55 1.13 1.9 60.8 57.1 - 64.0


HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)




Specimen CL-15

All Method 78 24.35 3.89 16.0 25.9 12.6 - 36.1



Orphee Mythic 22 16 17.77 2.93 16.5 17.9 8.9 - 26.6

12 /2015 MLE-M3 International Data Supplement

HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)




Specimen CL-15

All Method 78 8.36 4.80 57.4 6.0 0.0 - 22.8



Orphee Mythic 22 16 17.18 3.20 18.7 17.5 7.5 - 26.8


HEMATOLOGY W/ 5-PART DIFFERENTIALEOSINOPHILS (percent)




Specimen CL-15

All Method 75 4.61 0.37 8.0 4.6 3.5 - 5.8



Orphee Mythic 22 15 4.21 0.64 15.1 4.3 2.2 - 6.2


HEMATOLOGY W/ 5-PART DIFFERENTIALBASOPHILS (percent)




Specimen CL-15

All Method 74 0.40 0.25 62.2 0.4 0.0 - 1.2



Orphee Mythic 22 16 0.36 0.24 66.0 0.3 0.0 - 1.1


BLOOD BANK ABO GROUP

Specimen Results Labs Percent Performance

BB-11 Group O 133 99.25% Acceptable

Group AB 1 0.75%

BB-12 Group A 134 99.26% Acceptable

Group AB 1 0.74%

BB-13 Group B 128 97.71% Acceptable

Group AB 3 2.29%

BB-14 Group O 135 100% Acceptable

BB-15 Group A 135 99.26% Acceptable

Group O 1 0.74%

RH FACTOR (D TYPE)


BB-11 Rh Negative 134 99.26% Acceptable

Rh Positive 1 0.74%

BB-12 Rh Positive 135 99.26% Acceptable

Ph Negative 1 0.74%


Rh Negative 2 1.52%


Rh Negative 2 1.47%

BB-15 Rh Negative 136 99.27% Acceptable

Rh Positive 1 0.73%


ANTIBODY IDENTIFICATION

Specimen Identification Labs Percent Performance

AB-11 No antibody detected 45 93.75% Acceptable

Anti-c 1 2.08%

Anti-e 1 2.08%

Unable to identify, referred 1 2.08%


Anti-C 1 2.04%

Anti-c 1 2.04%

Anti-e 1 2.04%

Anti-k 1 2.04%

AB-13 AntiE 46 95.83% Acceptable

Anti-e 1 2.08%

Anti-c 1 2.08%


Anti-C 1 2.04%

Anti-c 1 2.04%

Anti-e 1 2.04%

Unable to identify, referred 1 2.04%

AB-15 Anit-D 45 93.75% Acceptable

Anti-e 1 2.08%

Anti-Fy(b) 1 2.08%

Anti-c 1 2.08%

Specimens AB-11, AB-12, AB-14 and AB-15 were graded by 100% referee consensus.

BLOOD BANK

UNEXPECTED ANTIBODY DETECTION


AB-11 No unexpected antibody detected 96 97.96% Acceptable

Unexpected antibody detected 2 2.04%



AB-13 Unexpected antibody detected 95 96.94% Acceptable

No unexpected antibody deteded 3 3.06%



AB-15 Unexpected antibody detected 96 97.96% Acceptable

No unexpected antibody detected 2 2.04%

Specimen AB-14 was graded by 100% referee consensus.


BLOOD BANK

COMPATIBILITY TESTING


AB-11 Compatible 104 96.30% Acceptable

Not Compatible 4 3.70%







AB-15 Not Compatible 102 94.44% Acceptable

Compatible 6 5.56%

Specimens AB-13, AB-14 and AB-15 were graded by 100% referee consensus.


Coagulation

PROTHROMBIN TIME (seconds)

Specimen CG-11 Specimen CG-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 131 29.34 4.64 15.8 30.4 24.9 - 33.8 130 50.68 9.88 19.5 52.6 43.0 - 58.3 Dade Innovin Dade Behring BFT II 5 25.78 2.05 7.9 25.5 21.9 - 29.7 5 44.98 3.85 8.6 44.3 38.2 - 51.8 Sysmex CA-500/600 series 26 25.29 0.89 3.5 25.2 21.4 - 29.1 26 42.64 1.77 4.1 42.5 36.2 - 49.1 All Coagulation Instruments 35 25.40 1.17 4.6 25.4 21.5 - 29.3 36 43.40 2.92 6.7 42.7 36.8 - 50.0 Diag Stago STA Neoplastine CI+ bioMerieux Thrombolyzer Compact X/XR 6 34.98 1.73 4.9 35.7 29.7 - 40.3 6 62.65 3.42 5.5 63.4 53.2 - 72.1 Diagnostica Stago STart 4/8 11 33.49 2.46 7.3 32.9 28.4 - 38.6 11 59.64 8.36 14.0 57.8 50.6 - 68.6 RAL Clot-SP 18 32.36 1.28 3.9 32.4 27.5 - 37.3 18 56.81 2.62 4.6 57.0 48.2 - 65.4 All Coagulation Instruments 41 33.02 1.70 5.1 32.9 28.0 - 38.0 41 58.02 4.85 8.4 57.8 49.3 - 66.8 Diagon Dia-PT Coalyzer-410 6 29.42 1.50 5.1 29.4 25.0 - 33.9 6 52.87 3.12 5.9 52.3 44.9 - 60.8 HemosIL RecombiPlasTin 2G IL ACL, all models 6 30.30 2.05 6.8 30.6 25.7 - 34.9 6 52.18 4.06 7.8 53.1 44.3 - 60.1 IL TEST PT Fibrinogen IL ACL, all models 9 20.89 0.67 3.2 21.0 17.7 - 24.1 9 31.33 1.23 3.9 31.7 26.6 - 36.1 IL TEST PT-FIB HS PLUS IL ACL, all models 15 32.89 2.60 7.9 33.8 27.9 - 37.9 15 58.05 2.67 4.6 58.8 49.3 - 66.8


PROTHROMBIN TIME (seconds) Specimen CG-13 Specimen CG-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 131 11.93 1.40 11.7 12.1 10.1 - 13.8 130 12.66 1.57 12.4 13.1 10.7 - 14.6 Dade Innovin Dade Behring BFT II 5 9.26 0.58 6.2 9.2 7.8 - 10.7 5 9.46 0.74 7.8 9.3 8.0 - 10.9 Sysmex CA-500/600 series 27 10.44 0.32 3.1 10.4 8.8 - 12.1 27 10.98 0.28 2.5 10.9 9.3 - 12.7 All Coagulation Instruments 36 10.22 0.62 6.1 10.3 8.6 - 11.8 36 10.68 0.75 7.0 10.9 9.0 - 12.3 Diag Stago STA Neoplastine CI+ bioMerieux Thrombolyzer Compact X/XR 6 12.77 0.34 2.7 12.9 10.8 - 14.7 6 13.30 0.46 3.5 13.3 11.3 - 15.3 Diagnostica Stago STart 4/8 11 12.66 0.85 6.7 12.4 10.7 - 14.6 11 13.80 1.02 7.4 13.5 11.7 - 15.9 RAL Clot-SP 18 13.38 0.48 3.6 13.4 11.3 - 15.4 18 14.11 0.46 3.2 14.1 11.9 - 16.3 All Coagulation Instruments 43 13.04 0.67 5.1 13.0 11.0 - 15.1 42 13.82 0.57 4.1 13.9 11.7 - 15.9 Diagon Dia-PT Coalyzer-410 6 12.43 0.76 6.1 12.3 10.5 - 14.3 6 14.05 2.42 17.3 13.5 11.9 - 16.2 HemosIL RecombiPlasTin 2G IL ACL, all models 6 11.17 0.30 2.7 11.2 9.4 - 12.9 6 12.33 0.33 2.7 12.4 10.4 - 14.2 IL TEST PT Fibrinogen IL ACL, all models 9 11.36 0.36 3.2 11.4 9.6 - 13.1 9 11.74 0.21 1.8 11.7 9.9 - 13.6 IL TEST PT-FIB HS PLUS IL ACL, all models 14 13.10 0.44 3.4 13.2 11.1 - 15.1 15 13.70 0.66 4.8 13.8 11.6 - 15.8


PROTHROMBIN TIME (seconds) Specimen CG-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 128 13.47 1.16 8.6 13.5 11.4 - 15.5 Dade Innovin Dade Behring BFT II 5 11.58 0.55 4.8 11.6 9.8 - 13.4 Sysmex CA-500/600 series 27 12.59 0.39 3.1 12.6 10.6 - 14.5 All Coagulation Instruments 36 12.37 0.61 4.9 12.5 10.5 - 14.3 Diag Stago STA Neoplastine CI+ bioMerieux Thrombolyzer Compact X/XR 6 14.23 0.44 3.1 14.2 12.0 - 16.4 Diagnostica Stago STart 4/8 11 13.95 1.57 11.3 13.5 11.8 - 16.1 RAL Clot-SP 18 14.83 0.55 3.7 14.7 12.6 - 17.1 All Coagulation Instruments 42 14.30 0.75 5.3 14.3 12.1 - 16.5 Diagon Dia-PT Coalyzer-410 5 13.22 0.76 5.7 13.0 11.2 - 15.3 HemosIL RecombiPlasTin 2G IL ACL, all models 6 12.10 0.47 3.9 12.4 10.2 - 14.0 IL TEST PT Fibrinogen IL ACL, all models 9 13.31 0.32 2.4 13.3 11.3 - 15.4 IL TEST PT-FIB HS PLUS IL ACL, all models 15 14.52 0.33 2.3 14.5 12.3 - 16.7


PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)

Specimen CG-11 Specimen CG-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 128 2.84 0.48 17.0 2.8 2.2 - 3.5 127 5.45 1.53 28.0 5.4 4.3 - 6.6 Dade Innovin Dade Behring BFT II 5 2.46 0.15 6.2 2.4 1.9 - 3.0 5 3.94 0.28 7.1 3.8 3.1 - 4.8 Sysmex CA-500/600 series 27 2.44 0.12 5.0 2.4 1.9 - 3.0 27 4.09 0.25 6.1 4.0 3.2 - 5.0 All Coagulation Instruments 36 2.44 0.13 5.5 2.5 1.9 - 3.0 36 4.06 0.27 6.7 4.0 3.2 - 4.9 Diag Stago STA Neoplastine CI+ bioMerieux Thrombolyzer Compact X/XR 6 3.65 0.54 14.8 3.9 2.9 - 4.4 6 7.70 1.29 16.8 8.0 6.1 - 9.3 Diagnostica Stago STart 4/8 9 3.42 0.33 9.7 3.4 2.7 - 4.2 9 7.24 0.97 13.4 7.2 5.7 - 8.7 RAL Clot-SP 16 3.23 0.22 6.9 3.2 2.5 - 3.9 16 6.77 0.52 7.7 6.9 5.4 - 8.2 All Coagulation Instruments 38 3.33 0.37 11.2 3.3 2.6 - 4.1 37 6.98 0.95 13.5 7.2 5.5 - 8.4 Diagon Dia-PT Coalyzer-410 6 2.82 0.29 10.1 2.9 2.2 - 3.4 6 5.88 0.87 14.8 5.7 4.7 - 7.1 HemosIL RecombiPlasTin 2G IL ACL, all models 7 2.80 0.23 8.2 2.8 2.2 - 3.4 7 4.93 0.51 10.3 5.0 3.9 - 6.0 IL TEST PT Fibrinogen IL ACL, all models 9 2.89 0.27 9.2 2.9 2.3 - 3.5 9 5.88 0.58 9.9 5.8 4.7 - 7.1 IL TEST PT-FIB HS PLUS IL ACL, all models 15 2.74 0.37 13.6 2.8 2.1 - 3.3 15 5.21 0.63 12.0 5.4 4.1 - 6.3


PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-13 Specimen CG-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 128 0.99 0.08 8.5 1.0 0.7 - 1.2 127 1.06 0.11 10.0 1.1 0.8 - 1.3 Dade Innovin Dade Behring BFT II 5 1.02 0.04 4.4 1.0 0.8 - 1.3 5 1.06 0.05 5.2 1.1 0.8 - 1.3 Sysmex CA-500/600 series 27 1.02 0.07 7.2 1.0 0.8 - 1.3 27 1.07 0.05 5.1 1.1 0.8 - 1.3 All Coagulation Instruments 36 1.02 0.07 7.1 1.0 0.8 - 1.3 36 1.07 0.06 5.5 1.1 0.8 - 1.3 Diag Stago STA Neoplastine CI+ bioMerieux Thrombolyzer Compact X/XR 6 0.98 0.10 10.0 1.0 0.7 - 1.2 6 1.02 0.12 11.5 1.1 0.8 - 1.3 Diagnostica Stago STart 4/8 9 0.97 0.10 10.3 0.9 0.7 - 1.2 9 1.07 0.14 13.3 1.0 0.8 - 1.3 RAL Clot-SP 16 1.00 0.07 7.3 1.0 0.8 - 1.2 16 1.06 0.06 5.8 1.1 0.8 - 1.3 All Coagulation Instruments 38 0.99 0.09 8.6 1.0 0.7 - 1.2 37 1.05 0.08 8.0 1.1 0.8 - 1.3 Diagon Dia-PT Coalyzer-410 6 0.95 0.08 8.8 0.9 0.7 - 1.2 5 1.14 0.32 28.2 1.0 0.9 - 1.4 HemosIL RecombiPlasTin 2G IL ACL, all models 7 1.00 0.06 5.8 1.0 0.8 - 1.2 7 1.11 0.07 6.2 1.1 0.8 - 1.4 IL TEST PT Fibrinogen IL ACL, all models 9 0.99 0.06 6.1 1.0 0.7 - 1.2 9 1.02 0.07 6.5 1.0 0.8 - 1.3 IL TEST PT-FIB HS PLUS IL ACL, all models 15 0.93 0.09 9.6 1.0 0.7 - 1.2 15 0.98 0.09 8.8 1.0 0.7 - 1.2


PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 126 1.14 0.12 10.5 1.1 0.9 - 1.4 Dade Innovin Dade Behring BFT II 5 1.28 0.04 3.5 1.3 1.0 - 1.6 Sysmex CA-500/600 series 27 1.21 0.08 6.2 1.2 0.9 - 1.5 All Coagulation Instruments 36 1.22 0.07 6.1 1.2 0.9 - 1.5 Diag Stago STA Neoplastine CI+ bioMerieux Thrombolyzer Compact X/XR 6 1.13 0.12 10.7 1.2 0.9 - 1.4 Diagnostica Stago STart 4/8 9 1.11 0.15 13.1 1.1 0.8 - 1.4 RAL Clot-SP 16 1.14 0.05 4.4 1.1 0.9 - 1.4 All Coagulation Instruments 38 1.12 0.10 8.9 1.1 0.8 - 1.4 Diagon Dia-PT Coalyzer-410 5 1.02 0.11 10.7 1.0 0.8 - 1.3 HemosIL RecombiPlasTin 2G IL ACL, all models 7 1.11 0.07 6.2 1.1 0.8 - 1.4 IL TEST PT Fibrinogen IL ACL, all models 9 1.28 0.07 5.2 1.3 1.0 - 1.6 IL TEST PT-FIB HS PLUS IL ACL, all models 14 1.07 0.05 4.4 1.1 0.8 - 1.3


ACTIVATED PARTIAL THROMBOPLASTIN (seconds)


All Method 74 52.0 7.6 14.6 49 44 - 60 75 78.4 14.8 18.9 71 66 - 91 Dade Actin Sysmex CA-500/600 series 3 74.3 7.8 10.4 72 63 - 86 3 110.7 13.7 12.3 117 94 - 128 All Coagulation Instruments 4 73.0 6.9 9.4 71 62 - 84 4 109.0 11.6 10.7 111 92 - 126 Dade Actin FSL Sysmex CA-500/600 series 14 47.1 1.3 2.8 48 40 - 55 14 69.2 2.0 3.0 70 58 - 80 All Coagulation Instruments 15 47.4 1.8 3.8 48 40 - 55 15 69.8 3.0 4.3 70 59 - 81 Diagnostica Stago STA C.K. Prest bioMerieux Thrombolyzer Compact X/XR 5 52.2 2.7 5.1 51 44 - 61 5 74.8 6.3 8.4 73 63 - 87 Diagnostica Stago STA Compact 3 49.0 2.6 5.4 48 41 - 57 4 73.3 4.3 5.9 74 62 - 85 Diagnostica Stago STart 4/8 5 50.6 5.1 10.1 52 43 - 59 4 81.3 9.1 11.3 83 69 - 94 All Coagulation Instruments 15 50.9 3.5 6.9 51 43 - 59 15 76.3 7.0 9.2 77 64 - 88 Diagnostica Stago STA-PTT All Coagulation Instruments 3 54.7 4.9 9.0 57 46 - 63 3 77.7 3.2 4.1 79 66 - 90 Diagon Dia-PTT Coalyzer-410 3 109.0 15.5 14.2 110 92 - 126 3 265.3 19.5 7.4 274 225 - 306 Hemoliance SynthASil IL ACL, all models 5 59.4 1.1 1.9 59 50 - 69 5 88.2 3.8 4.3 91 74 - 102 IL TEST APTT-SP IL ACL, all models 23 46.6 2.3 4.8 47 39 - 54 23 68.4 2.4 3.5 69 58 - 79


ACTIVATED PARTIAL THROMBOPLASTIN (seconds) Specimen CG-13 Specimen CG-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 80 27.7 3.1 11.1 27 23 - 32 78 32.4 3.2 9.9 31 27 - 38 Dade Actin Sysmex CA-500/600 series 3 26.7 1.5 5.7 27 22 - 31 2 - - - 36 29 - 40 All Coagulation Instruments 4 26.8 1.3 4.7 27 22 - 31 3 34.7 2.9 8.3 33 29 - 40 Dade Actin FSL Sysmex CA-500/600 series 14 24.6 0.5 2.0 25 20 - 29 13 30.5 0.7 2.2 31 25 - 36 All Coagulation Instruments 15 24.7 0.6 2.4 25 21 - 29 14 30.6 0.7 2.4 31 26 - 36 Diagnostica Stago STA C.K. Prest bioMerieux Thrombolyzer Compact X/XR 5 31.4 1.5 4.8 31 26 - 37 5 35.6 1.8 5.1 35 30 - 41 Diagnostica Stago STA Compact 4 29.8 1.5 5.0 29 25 - 35 4 34.3 1.3 3.7 34 29 - 40 Diagnostica Stago STart 4/8 4 29.0 2.7 9.3 30 24 - 34 4 32.8 3.9 11.8 35 27 - 38 All Coagulation Instruments 15 30.2 1.9 6.4 30 25 - 35 15 34.2 2.4 7.1 34 29 - 40 Diagnostica Stago STA-PTT All Coagulation Instruments 4 32.5 2.4 7.3 33 27 - 38 4 37.3 3.2 8.6 38 31 - 43 Diagon Dia-PTT Coalyzer-410 3 30.3 2.5 8.3 30 25 - 35 3 35.3 4.0 11.4 36 30 - 41 Hemoliance SynthASil IL ACL, all models 5 31.0 0.1 0.0 31 26 - 36 5 31.2 0.4 1.4 31 26 - 36 IL TEST APTT-SP IL ACL, all models 24 25.6 1.0 3.8 25 21 - 30 24 30.4 2.0 6.5 30 25 - 35 Specimen CG-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 79 36.2 5.3 14.5 35 30 - 42

Dade Actin

Sysmex CA-500/600 series 2 - - - 33 27 - 38

All Coagulation Instruments 3 32.7 1.5 4.7 33 27 - 38 Dade Actin FSL

Sysmex CA-500/600 series 14 29.0 0.1 0.0 29 24 - 34

All Coagulation Instruments 14 29.0 0.1 0.0 29 24 - 34 Diagnostica Stago STA C.K. Prest

bioMerieux Thrombolyzer Compact X/XR 5 41.2 1.8 4.3 41 35 - 48 Diagnostica Stago STA Compact 4 38.3 1.3 3.3 38 32 - 44

Diagnostica Stago STart 4/8 4 37.5 3.1 8.3 39 31 - 44

All Coagulation Instruments 15 39.1 2.4 6.2 39 33 - 46 Diagnostica Stago STA-PTT

All Coagulation Instruments 4 42.8 2.2 5.2 43 36 - 50

Diagon Dia-PTT Coalyzer-410 3 38.3 1.2 3.0 39 32 - 45

Hemoliance SynthASil IL ACL, all models 5 46.8 1.1 2.3 46 39 - 54

IL TEST APTT-SP

IL ACL, all models 24 34.9 1.1 3.1 35 29 - 41


FIBRINOGEN (mg/dL)


All Method 33 328.3 46.9 14.3 320 262 - 394 34 337.3 51.1 15.2 336 269 - 405 Diagnostica Stago STA Fibrinogen bioMerieux Thrombolyzer Compact X/XR 4 - - - 278 231 - 348 5 281.6 18.6 6.6 289 225 - 338 All Coagulation Instruments 8 289.6 35.4 12.2 295 231 - 348 9 285.3 15.1 5.3 289 228 - 343 IL TEST PT-FIB HS PLUS IL ACL, all models 11 358.1 30.6 8.5 363 286 - 430 12 379.0 35.7 9.4 376 303 - 455 IL TEST PT-FIB Recombinant IL ACL, all models 5 370.2 45.8 12.4 379 296 - 445 5 370.2 49.6 13.4 366 296 - 445


All Method 36 357.7 31.4 8.8 349 286 - 430 31 546.1 51.6 9.4 540 436 - 656 Diagnostica Stago STA Fibrinogen bioMerieux Thrombolyzer Compact X/XR 5 339.2 35.1 10.3 345 271 - 408 4 - - - 557 438 - 658 All Coagulation Instruments 9 342.2 27.4 8.0 345 273 - 411 8 548.0 39.3 7.2 540 438 - 658 IL TEST PT-FIB HS PLUS IL ACL, all models 12 359.3 29.3 8.2 354 287 - 432 12 543.2 50.8 9.3 532 434 - 652 IL TEST PT-FIB Recombinant IL ACL, all models 5 382.8 21.4 5.6 383 306 - 460 5 578.6 43.1 7.5 579 462 - 695

Specimen CG-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 34 151.3 22.6 15.0 151 121 - 182 Diagnostica Stago STA Fibrinogen bioMerieux Thrombolyzer Compact X/XR 5 146.8 16.8 11.4 153 117 - 177 All Coagulation Instruments 9 151.0 13.5 8.9 153 120 - 182 IL TEST PT-FIB HS PLUS IL ACL, all models 10 143.2 15.0 10.5 144 114 - 172 IL TEST PT-FIB Recombinant IL ACL, all models 5 134.2 20.5 15.3 127 107 - 162


URINALYSIS DIPSTICKSPECIFIC GRAVITY

Specimen UA-3 Method Labs Mean SD CV Median Range

All Method 423 1.0156 0.0049 0.5 1.015 1.005 - 1.026 All Refractive Index Methods 11 1.0204 0.0041 0.4 1.020 1.010 - 1.031 All Roche Methods 142 1.0141 0.0043 0.4 1.015 1.004 - 1.025 All Siemens Methods 49 1.0142 0.0041 0.4 1.015 1.004 - 1.025 Arkray Aution Sticks 15 1.0221 0.0058 0.6 1.020 1.012 - 1.033 Combi-Screen Test Strips 12 1.0146 0.0025 0.3 1.015 1.004 - 1.025 DIRUI H-100 / H-500 Urine Analyzer 19 1.0142 0.0020 0.2 1.015 1.004 - 1.025 Other Analyzer Method 14 1.0191 0.0053 0.5 1.021 1.009 - 1.030 Roche Chemstrips / Combur 27 1.0111 0.0032 0.3 1.010 1.001 - 1.022 Roche cobas u 411 87 1.0132 0.0034 0.3 1.015 1.003 - 1.024 Roche Urisys 48 1.0163 0.0049 0.5 1.019 1.006 - 1.027 SD UroColor Reagent Strips 23 1.0211 0.0036 0.4 1.020 1.011 - 1.032 Siemens Clinitek Advantus 30 1.0125 0.0029 0.3 1.010 1.002 - 1.023 Siemens Clinitek Status / Status+ 10 1.0165 0.0024 0.2 1.015 1.006 - 1.027 UriScan Reagent Strips 34 1.0178 0.0051 0.5 1.020 1.007 - 1.028


URINALYSIS DIPSTICKpH

Specimen UA-3 Participant Results

Method Labs ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0

ALL METHODS 443 - - - - 1 7 71 345 16 3 - - Acon Laboratories 9 - - - - - - 2 6 - 1 - - Analyticon CombiScan 500 2 - - - - - 1 - 1 - - - - Arkray Aution Jet 3 - - - - - - 1 2 - - - - Arkray Aution Sticks 15 - - - - - - 5 9 1 - - - Arkray PocketChem UA 3 - - - - - - - 3 - - - - Combi-Screen Test Strips 14 - - - - - - - 14 - - - - Diagnostic Test Group Clarity Urocheck 1 - - - - - - - 1 - - - - DIRUI H-100 / H-500 Urine Analyzer 21 - - - - - - 9 6 6 - - - DIRUI H-800 Urine Analyzer 7 - - - - - - 1 5 1 - - - HUMAN Combilyzer 2 - - - - - - - 2 - - - - Iris Diagnostics Aution Max AX-4280 2 - - - - - - 1 1 - - - - Iris Diagnostics iChem Velocity Strips 8 - - - - - - 6 2 - - - - Other Analyzer Method 16 - - - - - - 8 8 - - - - Other Dipstick Method 8 - - - - - 2 3 2 - 1 - - Plasmatec URIPATH 2 - - - - - - - 2 - - - - Roche Chemstrip 101 5 - - - - - - - 5 - - - - Roche Chemstrips / Combur 29 - - - - - - - 28 - 1 - - Roche cobas u 411 87 - - - - - - 2 85 - - - - Roche Miditron Junior/II 2 - - - - - - - 2 - - - - Roche Urilux S 2 - - - - - - - 2 - - - - Roche Urisys 49 - - - - - - 1 47 1 - - - SD UroColor Reagent Strips 24 - - - - 1 - 7 15 1 - - - Siemens Clinitek 50 1 - - - - - - - - 1 - - - Siemens Clinitek 500 2 - - - - - - - 2 - - - - Siemens Clinitek Advantus 30 - - - - - - 2 28 - - - - Siemens Clinitek Atlas 6 - - - - - - - 6 - - - - Siemens Clinitek Status / Status+ 11 - - - - - - - 11 - - - - Siemens Multistix Pro 6 - - - - - - - 5 1 - - - Siemens Reagent Strips 18 - - - - - - - 14 4 - - - TECO URS Strips 1 - - - - - - 1 - - - - - Urinometer 2 - - - - - - - 2 - - - - UriScan Pro/II 8 - - - - - 1 4 3 - - - - UriScan Reagent Strips 34 - - - - - 3 15 16 - - - - URIT Medical Uritest Reagent Strips 1 - - - - - - - 1 - - - -


URINALYSIS DIPSTICKPROTEIN QUALITATIVE

Specimen UA-3

Participant Results

Method Labs Negative Trace (1+)

(2+)

(3+)

(4+)

10 - 20 mg/dL

30 - 70 mg/dL

75 mg/dL

100 - 200 mg/dL

≥300 - 600 mg/dL

>600 or ≥1000 mg/dL

ALL METHODS 444 438 - 1 1 1 1 - - - 2 - - Acon Laboratories 9 8 - 1 - - - - - - - - - Analyticon CombiScan 500 2 2 - - - - - - - - - - - Arkray Aution Jet 3 3 - - - - - - - - - - - Arkray Aution Sticks 15 15 - - - - - - - - - - - Arkray PocketChem UA 3 3 - - - - - - - - - - - Combi-Screen Test Strips 14 14 - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 1 1 - - - - - - - - - - - DIRUI H-100 / H-500 Urine Analyzer 22 22 - - - - - - - - - - - DIRUI H-800 Urine Analyzer 6 6 - - - - - - - - - - - HUMAN Combilyzer 2 1 - - - - - - - - 1 - - Iris Diagnostics Aution Max AX-4280 2 2 - - - - - - - - - - - Iris Diagnostics iChem Velocity Strips 8 8 - - - - - - - - - - - Other Analyzer Method 17 17 - - - - - - - - - - - Other Dipstick Method 9 9 - - - - - - - - - - - Plasmatec URIPATH 2 2 - - - - - - - - - - - Roche Chemstrip 101 5 5 - - - - - - - - - - - Roche Chemstrips / Combur 31 30 - - 1 - - - - - - - - Roche cobas u 411 89 88 - - - 1 - - - - - - - Roche Miditron Junior/II 2 2 - - - - - - - - - - - Roche Urilux S 2 2 - - - - - - - - - - - Roche Urisys 48 47 - - - - - - - - 1 - - SD UroColor Reagent Strips 24 24 - - - - - - - - - - - Siemens Clinitek 50 1 1 - - - - - - - - - - - Siemens Clinitek 500 2 2 - - - - - - - - - - - Siemens Clinitek Advantus 30 30 - - - - - - - - - - - Siemens Clinitek Atlas 6 6 - - - - - - - - - - - Siemens Clinitek Status / Status+ 12 12 - - - - - - - - - - - Siemens Multistix Pro 6 6 - - - - - - - - - - - Siemens Reagent Strips 16 16 - - - - - - - - - - - TECO URS Strips 1 1 - - - - - - - - - - - Urinometer 2 2 - - - - - - - - - - - UriScan Pro/II 8 7 - - - - 1 - - - - - - UriScan Reagent Strips 33 33 - - - - - - - - - - - URIT Medical Uritest Reagent Strips 1 1 - - - - - - - - - - -


URINALYSIS DIPSTICKGLUCOSE

Specimen UA-3 Participant Results Method Labs Negative Trace

(1+)

(2+)

(3+)

(4+)

30 - 100 mg/dL

150 - 300

mg/dL

500 mg/dL

>500 or ≥1000 or

≥2000 mg/dL

ALL METHODS 447 4 1 9 56 65 76 - 14 53 169

Acon Laboratories 9 - - 1 2 1 2 - 2 1 -

Analyticon CombiScan 500 2 - - - - - - - - 1 1

Arkray Aution Jet 3 - - - - 1 2 - - - -

Arkray Aution Sticks 16 - - - - - 8 - - 3 5

Arkray PocketChem UA 3 - - - - - 2 - - - 1

Combi-Screen Test Strips 13 - - - - - - - 1 5 7

Diagnostic Test Group Clarity Urocheck 1 - - - 1 - - - - - -

DIRUI H-100 / H-500 Urine Analyzer 22 - - 1 5 6 1 - 3 6 -

DIRUI H-800 Urine Analyzer 6 - - - 1 1 2 - 1 1 -

HUMAN Combilyzer 2 1 - - - - - - - 1 -

Iris Diagnostics Aution Max AX-4280 2 - - - - - 1 - - - 1

Iris Diagnostics iChem Velocity Strips 8 - - - - 2 - - 1 5 -

Other Analyzer Method 17 - - - - 1 6 - 2 1 7

Other Dipstick Method 9 - - - 2 3 - - 1 2 1

Plasmatec URIPATH 2 - - 1 1 - - - - - -

Roche Chemstrip 101 5 - - - - - - - - - 5

Roche Chemstrips / Combur 30 - - - 1 2 17 - - 1 9

Roche cobas u 411 89 1 - - - 2 11 - 1 - 74

Roche Miditron Junior/II 2 - - - - - 1 - - - 1

Roche Urilux S 2 - - - - - 2 - - - -

Roche Urisys 49 1 - - 1 1 11 - 1 - 34

SD UroColor Reagent Strips 24 - - - 7 10 2 - - 1 4

Serim Blood Leak Strips 1 - - - 1 - - - - - -

Siemens Clinitek 50 1 1 - - - - - - - - -

Siemens Clinitek 500 2 - - - - - - - - 1 1

Siemens Clinitek Advantus 30 - - 1 12 6 - - - 8 3

Siemens Clinitek Atlas 6 - - - 1 3 - - - 1 1

Siemens Clinitek Status / Status+ 12 - - - 7 1 - - - 3 1

Siemens Multistix Pro 6 - - - - 2 - - - 3 1

Siemens Reagent Strips 18 - - 5 1 6 - - - 2 4

Urinometer 2 - - - - 2 - - - - -

UriScan Pro/II 8 - - - 1 3 - - - - 4

UriScan Reagent Strips 33 - - - 11 10 3 - 1 4 4

URIT Medical Uritest Analyzers 1 - - - - 1 - - - - -

URIT Medical Uritest Reagent Strips 1 - - - - - - - - 1 -


URINALYSIS DIPSTICKKETONES

Specimen UA-3

Participant Results

Method Labs Negative Trace Small

Moderate

Large

(1+)

(2+)

(3+)

(4+)

5 - 10 mg/dL

15 - 20 mg/dL

40 - 60 mg/dL

80 - 100 mg/dL

≥150 mg/dL

ALL METHODS 444 4 - - - 11 3 21 129 69 1 1 7 49 149 Acon Laboratories 9 - - - - - - - 3 4 - - - - 2 Analyticon CombiScan 500 2 - - - - - - - - - - - - - 2 Arkray Aution Jet 3 - - - - - - - - 3 - - - - - Arkray Aution Sticks 16 - - - - - - - 1 8 - - 1 3 3 Arkray PocketChem UA 3 - - - - - - - - 2 - - - - 1 Combi-Screen Test Strips 13 - - - - - - - 2 - - - - 1 10 Diagnostic Test Group Clarity Urocheck 1 - - - - - - - 1 - - - - - - DIRUI H-100 / H-500 Urine Analyzer 22 - - - - - - - 13 1 1 - - 6 1 DIRUI H-800 Urine Analyzer 5 - - - - - 1 - 2 1 - - - 1 - HUMAN Combilyzer 2 1 - - - - - - 1 - - - - - - Iris Diagnostics Aution Max AX-4280 2 - - - - - - - - 1 - - - - 1 Iris Diagnostics iChem Velocity Strips 8 - - - - - - - - - - - - 4 4 Other Analyzer Method 18 - - - - - 1 - 4 3 - - 1 3 6 Other Dipstick Method 9 - - - - 1 - 1 5 - - - - 1 1 Plasmatec URIPATH 2 - - - - - - - 2 - - - - - - Roche Chemstrip 101 5 - - - - - - 1 4 - - - - - - Roche Chemstrips / Combur 29 - - - - 3 - - 20 2 - - - - 4 Roche cobas u 411 89 1 - - - - - - 5 10 - - - 1 72 Roche Miditron Junior/II 2 - - - - - - - - 1 - - - - 1 Roche Urilux S 2 - - - - - - - 1 1 - - - - - Roche Urisys 48 1 - - - - - 1 7 5 - - 2 - 32 SD UroColor Reagent Strips 24 - - - - - - 14 3 2 - - 2 3 - Siemens Clinitek 50 1 1 - - - - - - - - - - - - - Siemens Clinitek 500 2 - - - - - - - - - - - - 1 1 Siemens Clinitek Advantus 30 - - - - 1 - - 18 - - - - 9 2 Siemens Clinitek Atlas 6 - - - - - - - 3 1 - - - 2 - Siemens Clinitek Status / Status+ 12 - - - - - - - 2 7 - - - 1 2 Siemens Multistix Pro 6 - - - - 2 - - 1 2 - - - 1 - Siemens Reagent Strips 17 - - - - 3 - - 1 10 - - - - 3 TECO URS Strips 1 - - - - 1 - - - - - - - - - Urinometer 2 - - - - - - 1 1 - - - - - - UriScan Pro/II 7 - - - - - 1 - 4 - - - - 2 - UriScan Reagent Strips 34 - - - - - - 3 19 2 - - 1 9 - URIT Medical Uritest Analyzers 1 - - - - - - - 1 - - - - - - URIT Medical Uritest Reagent Strips 1 - - - - - - - 1 - - - - - -


URINALYSIS DIPSTICKBILIRUBIN

Specimen UA-3

Participant Results

Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 0.5 - 1.0 mg/dL

2.0 - 4.0 mg/dL

6.0 - 10.0 mg/dL

>10.0 mg/dL

ALL METHODS 436 435 - - - - - - 1 - - - - - Acon Laboratories 9 9 - - - - - - - - - - - - Analyticon CombiScan 500 3 3 - - - - - - - - - - - - Arkray Aution Jet 3 3 - - - - - - - - - - - - Arkray Aution Sticks 16 16 - - - - - - - - - - - - Arkray PocketChem UA 3 3 - - - - - - - - - - - - Combi-Screen Test Strips 12 12 - - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 1 1 - - - - - - - - - - - - DIRUI H-100 / H-500 Urine Analyzer 22 22 - - - - - - - - - - - - DIRUI H-800 Urine Analyzer 5 5 - - - - - - - - - - - - HUMAN Combilyzer 2 2 - - - - - - - - - - - - Iris Diagnostics Aution Max AX-4280 2 2 - - - - - - - - - - - - Iris Diagnostics iChem Velocity Strips 8 8 - - - - - - - - - - - - Other Analyzer Method 18 18 - - - - - - - - - - - - Other Dipstick Method 9 9 - - - - - - - - - - - - Plasmatec URIPATH 2 2 - - - - - - - - - - - - Roche Chemstrip 101 5 5 - - - - - - - - - - - - Roche Chemstrips / Combur 29 29 - - - - - - - - - - - - Roche cobas u 411 89 89 - - - - - - - - - - - - Roche Miditron Junior/II 2 2 - - - - - - - - - - - - Roche Urilux S 2 2 - - - - - - - - - - - - Roche Urisys 49 49 - - - - - - - - - - - - SD UroColor Reagent Strips 24 24 - - - - - - - - - - - - Siemens Clinitek 50 1 1 - - - - - - - - - - - - Siemens Clinitek 500 2 2 - - - - - - - - - - - - Siemens Clinitek Advantus 30 30 - - - - - - - - - - - - Siemens Clinitek Atlas 6 6 - - - - - - - - - - - - Siemens Clinitek Status / Status+ 11 11 - - - - - - - - - - - - Siemens Multistix Pro 6 6 - - - - - - - - - - - - Siemens Reagent Strips 8 8 - - - - - - - - - - - - TECO URS Strips 1 1 - - - - - - - - - - - - Urinometer 2 2 - - - - - - - - - - - - UriScan Pro/II 8 7 - - - - - - 1 - - - - - UriScan Reagent Strips 34 34 - - - - - - - - - - - - URIT Medical Uritest Analyzers 1 1 - - - - - - - - - - - - URIT Medical Uritest Reagent Strips 1 1 - - - - - - - - - - - -


URINALYSIS DIPSTICKUROBILINOGEN Specimen UA-3 Participant Results

Method Labs Neg or 0.0 - 0.2 mg/dL

1.0 or <2.0 mg/dL

2.0/3.0 mg/dL

4.0 or 4.0/6.0 mg/dL

≥8.0 or ≥12.0 mg/dL

ALL METHODS 433 423 3 4 2 1 Acon Laboratories 9 9 - - - - Analyticon CombiScan 500 3 3 - - - - Arkray Aution Jet 3 3 - - - - Arkray Aution Sticks 15 15 - - - - Arkray PocketChem UA 2 2 - - - - Combi-Screen Test Strips 12 12 - - - - Diagnostic Test Group Clarity Urocheck 1 1 - - - - DIRUI H-100 / H-500 Urine Analyzer 22 21 - 1 - - DIRUI H-800 Urine Analyzer 6 5 - - 1 - HUMAN Combilyzer 2 2 - - - - Iris Diagnostics Aution Max AX-4280 2 2 - - - - Iris Diagnostics iChem Velocity Strips 8 7 1 - - - Other Analyzer Method 17 16 1 - - - Other Dipstick Method 9 8 - 1 - - Plasmatec URIPATH 2 2 - - - - Roche Chemstrip 101 5 5 - - - - Roche Chemstrips / Combur 29 29 - - - - Roche cobas u 411 88 88 - - - - Roche Miditron Junior/II 2 2 - - - - Roche Urilux S 2 2 - - - - Roche Urisys 49 48 - - 1 - SD UroColor Reagent Strips 24 24 - - - - Siemens Clinitek 50 1 1 - - - - Siemens Clinitek 500 2 2 - - - - Siemens Clinitek Advantus 30 30 - - - - Siemens Clinitek Atlas 6 5 - 1 - - Siemens Clinitek Status / Status+ 11 10 - 1 - - Siemens Multistix Pro 6 6 - - - - Siemens Reagent Strips 8 8 - - - - TECO URS Strips 1 - 1 - - - Urinometer 2 2 - - - - UriScan Pro/II 8 7 - - - 1 UriScan Reagent Strips 34 34 - - - - URIT Medical Uritest Analyzers 1 1 - - - - URIT Medical Uritest Reagent Strips 1 1 - - - -


URINALYSIS DIPSTICKBLOOD/HEMOGLOBIN Specimen UA-3

Participant Results

Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) (5+) 5 - 25 Ery/µL

50 - 100

Ery/µL

250 Ery/µL

±0.03 mg/dL

0.06 -

0.10 mg/dL

0.2 - 0.5 mg/dL

≥ 1.0 mg/ dL

ALL METHODS 443 429 4 - - - 2 1 2 1 1 1 - 2 - - - - Acon Laboratories 9 9 - - - - - - - - - - - - - - - - Analyticon CombiScan 500 2 2 - - - - - - - - - - - - - - - - Arkray Aution Jet 3 3 - - - - - - - - - - - - - - - - Arkray Aution Sticks 16 16 - - - - - - - - - - - - - - - - Arkray PocketChem UA 3 3 - - - - - - - - - - - - - - - - Combi-Screen Test Strips 11 11 - - - - - - - - - - - - - - - -

Diagnostic Test Group Clarity Urocheck 1 1 - - - - - - - - - - - - - - - -

DIRUI H-100 / H-500 Urine Analyzer 22 22 - - - - - - - - - - - - - - - - DIRUI H-800 Urine Analyzer 5 5 - - - - - - - - - - - - - - - - HUMAN Combilyzer 2 1 - - - - - - - - - - - 1 - - - - Iris Diagnostics Aution Max AX-4280 2 2 - - - - - - - - - - - - - - - -

Iris Diagnostics iChem Velocity Strips 8 8 - - - - - - - - - - - - - - - - Other Analyzer Method 18 18 - - - - - - - - - - - - - - - - Other Dipstick Method 9 6 2 - - - - 1 - - - - - - - - - - Plasmatec URIPATH 2 2 - - - - - - - - - - - - - - - - Roche Chemstrip 101 5 4 - - - - - - - - - - - 1 - - - - Roche Chemstrips / Combur 29 28 - - - - - - 1 - - - - - - - - - Roche cobas u 411 88 84 - - - - 2 - - - 1 1 - - - - - - Roche Miditron Junior/II 2 2 - - - - - - - - - - - - - - - - Roche Urilux S 2 2 - - - - - - - - - - - - - - - - Roche Urisys 49 48 - - - - - - - 1 - - - - - - - - SD UroColor Reagent Strips 24 23 1 - - - - - - - - - - - - - - - Siemens Clinitek 50 1 1 - - - - - - - - - - - - - - - - Siemens Clinitek 500 2 2 - - - - - - - - - - - - - - - - Siemens Clinitek Advantus 30 30 - - - - - - - - - - - - - - - - Siemens Clinitek Atlas 6 6 - - - - - - - - - - - - - - - - Siemens Clinitek Status / Status+ 12 12 - - - - - - - - - - - - - - - - Siemens Multistix Pro 6 6 - - - - - - - - - - - - - - - - Siemens Reagent Strips 17 17 - - - - - - - - - - - - - - - - TECO URS Strips 1 1 - - - - - - - - - - - - - - - - Urinometer 2 2 - - - - - - - - - - - - - - - - UriScan Pro/II 8 7 - - - - - - 1 - - - - - - - - - UriScan Reagent Strips 34 34 - - - - - - - - - - - - - - - - URIT Medical Uritest Analyzers 1 1 - - - - - - - - - - - - - - - -

URIT Medical Uritest Reagent Strips 1 1 - - - - - - - - - - - - - - - -


URINALYSIS DIPSTICKLEUKOCYTE ESTERASE

Specimen UA-3

Participant Results

Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 25 µL 75 or 100 µL

250 or 500 µL

ALL METHODS 427 5 - 2 4 4 6 86 112 2 - 21 185 Acon Laboratories 9 - - - - - - 5 2 - - 2 - Analyticon CombiScan 500 3 - - - - - - - - - - - 3 Arkray Aution Jet 2 - - - - - - - - - - - 2 Arkray Aution Sticks 16 - - - - - - - - - - - 16 Arkray PocketChem UA 3 - - - - - - - - - - - 3 Combi-Screen Test Strips 11 - - - - - - - - - - - 11 Diagnostic Test Group Clarity Urocheck 1 - - - - - 1 - - - - - - DIRUI H-100 / H-500 Urine Analyzer 23 - - - - - - 9 6 - - 4 4 DIRUI H-800 Urine Analyzer 5 - - - - - - 1 3 - - - 1 HUMAN Combilyzer 2 1 - - - - - - 1 - - - - Iris Diagnostics Aution Max AX-4280 2 - - - - - - - - - - - 2 Iris Diagnostics iChem Velocity Strips 8 - - - - - - - 4 - - - 4 Other Analyzer Method 17 - - - - - - 3 5 1 - 1 7 Other Dipstick Method 7 - - - - - - 1 2 - - - 4 Plasmatec URIPATH 2 - - - - - - - 2 - - - - Roche Chemstrip 101 6 - - - - - - 4 2 - - - - Roche Chemstrips / Combur 27 - - - - - - 9 16 - - - 2 Roche cobas u 411 87 1 - - - - - 1 12 - - - 73 Roche Miditron Junior/II 2 - - - - - - - 1 - - - 1 Roche Urilux S 2 - - - - - - - 2 - - - - Roche Urisys 49 1 - - - - - 1 11 - - - 36 SD UroColor Reagent Strips 24 1 - - - - - 10 8 - - 2 3 Siemens Clinitek 50 1 1 - - - - - - - - - - - Siemens Clinitek 500 2 - - - - - - 1 - - - 1 - Siemens Clinitek Advantus 30 - - - 1 - - 20 1 - - 6 2 Siemens Clinitek Atlas 6 - - - - 1 - - 4 - - - 1 Siemens Clinitek Status / Status+ 11 - - 2 1 1 3 4 - - - - - Siemens Multistix Pro 6 - - - - - - 5 - - - 1 - Siemens Reagent Strips 8 - - - 2 1 - 3 2 - - - - TECO URS Strips 1 - - - - 1 - - - - - - - Urinometer 2 - - - - - - 1 1 - - - - UriScan Pro/II 8 - - - - - 1 - 5 - - - 2 UriScan Reagent Strips 34 - - - - - 1 5 17 1 - 4 6


URINALYSIS DIPSTICKNITRITE

Specimen UA-3

Participant Results

Method Labs Positive Negative

ALL METHODS 434 429 5 Acon Laboratories 10 9 1 Analyticon CombiScan 500 3 3 - Arkray Aution Jet 3 3 - Arkray Aution Sticks 15 15 - Arkray PocketChem UA 3 3 - Combi-Screen Test Strips 12 12 - Diagnostic Test Group Clarity Urocheck 1 1 - DIRUI H-100 / H-500 Urine Analyzer 22 22 - DIRUI H-800 Urine Analyzer 5 5 - HUMAN Combilyzer 2 1 1 Iris Diagnostics Aution Max AX-4280 2 2 - Iris Diagnostics iChem Velocity Strips 8 8 - Other Analyzer Method 18 18 - Other Dipstick Method 9 9 - Plasmatec URIPATH 2 2 - Roche Chemstrip 101 5 5 - Roche Chemstrips / Combur 29 29 - Roche cobas u 411 87 86 1 Roche Miditron Junior/II 2 2 - Roche Urilux S 2 2 - Roche Urisys 49 48 1 SD UroColor Reagent Strips 25 25 - Siemens Clinitek 50 1 - 1 Siemens Clinitek 500 2 2 - Siemens Clinitek Advantus 30 30 - Siemens Clinitek Atlas 5 5 - Siemens Clinitek Status / Status+ 11 11 - Siemens Multistix Pro 6 6 - Siemens Reagent Strips 8 8 - TECO URS Strips 1 1 - Urinometer 2 2 - UriScan Pro/II 8 8 - UriScan Reagent Strips 34 34 - URIT Medical Uritest Analyzers 1 1 - URIT Medical Uritest Reagent Strips 1 1 -


URINALYSIS MICROALBUMIN (dipstick only)

Specimen UA-3

Participant Results

Method Labs Negative 10 mg/L

20 mg/L

30 mg/L

50 mg/L

80 mg/L

100 mg/L

150 mg/L + (4 - 8 mg/dL)

++ (>8 mg/dL)

ALL METHODS 19 2 4 5 2 - - - - 1 - Beckman Coulter ICON microALB 1 1 - - - - - - - - - HUMAN COMBINA Test Strips 1 - 1 - - - - - - - - Roche Micral - 1 minute 5 1 - 4 - - - - - - - Siemens Clinitek Microalbumin 3 - 3 - - - - - - - -

URINALYSIS URINE hCG

Specimen UA-3 Participant Results

Method Labs

Positive

Negative

ALL METHODS 124 - 124 Acon Laboratories 12 - 12 Alere Acceava hCG-Urine 1 - 1 Alere Clearview hCG Cassette 6 - 6 Beckman Coulter ICON 25 hCG 2 - 2 Biotron 1-Step 7 - 7 Henry Schein One Step 2 - 2 PEP (Lab Supply) HCG 1 - 1 Quidel QuickVue + One-Step 3 - 3 Quidel QuickVue One-Step Combo 18 - 18 Quidel QuickVue One-Step Urine 9 - 9 RefuAH hCG Dipstick 1 - 1 Stanbio QuStick 1 - 1 Sure-Vue hCG - 25mIU 2 - 2


ANTIMICROBIAL SUSCEPTIBILIY TESTING

Specimen SUS-11 ------Disk Diffusion------ ------MIC------

Interpretative category data Interpretative category data

Antimicrobial Labs S I R Labs S I R Acceptable (%)

Amikacin 50 43 4 3 157 133 5 19 83.33%

Amoxicillin/Clavulanate 35 - - 35 21 - - 21 Inappropriate drug1

Ampicillin 19 - - 19 46 1 - 45 Inappropriate drug 1

Ampicillin/Sulbactam 17 - - 17 44 1 - 43 Inappropriate drug 1

Aztreonam 24 22 1 1 72 67 - 5 92.00%

Carbenicillin 2 - - 2 1 - - 1 Inappropriate drug 1

Cefaclor 6 - - 6 2 - - 2 Inappropriate drug 1

Cefazolin 3 - - 3 22 - - 22 Inappropriate drug 1

Cefepime 43 30 4 9 166 144 12 10 83.49%

Cefixime 13 1 - 12 5 - - 5 Inappropriate drug 1

Cefoperazone 9 9 - - 2 1 1 - Inappropriate drug 1

Cefotaxime 19 6 3 10 30 2 5 23 Inappropriate drug 1

Cefotetan - - - - 1 - - 1 Inappropriate drug 1

Cefoxitin 8 - - 8 32 - - 32 Inappropriate drug 1

Cefpodoxime - - - - 2 - - 2 Inappropriate drug 1

Ceftazidime 51 46 - 5 169 156 6 7 91.63%

Ceftizoxime 2 - - 2 - - - - Inappropriate drug 1

Ceftriaxone 36 17 8 11 43 2 2 39 Inappropriate drug 1

Cefuroxime 22 1 - 21 35 - 1 34 Inappropriate drug 1

Cephalexin 5 - - 5 3 - - 3 Inappropriate drug 1

Cephalothin 12 - - 12 18 1 - 17 Inappropriate drug 1

Ciprofloxacin 69 41 18 10 176 83 86 7 93.33%

Colistin 3 3 - - 12 12 - - 100.00%

Doripenem 1 1 - - 10 10 - - 100.00%

Doxycycline 4 - - 4 1 - - 1 Inappropriate drug 1

Ertapenem 4 - - 4 14 9 - 5 Inappropriate drug 1

Fosfomycin 5 4 - 1 7 - - 7 Inappropriate drug 1

Gatifloxacin 2 - - 2 1 1 - - Not graded2

Gentamicin 58 39 12 7 158 27 96 35 Referee grading3

Imipenem 44 44 - - 126 123 2 1 98.29%

1 This is an inappropriate drug for organism and/or source.

2 This is an ungraded challenge due to lack of comparison group.

3 This specimen was graded by 92% referee consensus.


4 This is an ungraded challenge due to lack of referee consensus.



ANTIMICROBIAL SUSCEPTIBILIY TESTING (cont’d)

Specimen SUS-11 ------Disk Diffusion------ ------MIC------

Interpretative category data Interpretative category data

Antimicrobial Labs S I R Labs S I R Acceptable (%)

Kanamycin - - - - 1 - - 1 Inappropriate drug 1

Levofloxacin 32 11 7 14 57 5 24 28 83.16%

Linezolid 1 - - 1 - - - - Inappropriate drug 1

Lomefloxacin 2 1 - 1 - - - - Not graded2

Meropenem 36 36 - - 152 152 - - 100.00%

Methicillin 1 - - 1 1 - 1 - Inappropriate drug 1

Minocycline 1 - - 1 3 - 1 2 Inappropriate drug 1

Moxifloxacin 8 - 2 6 1 - - 1 Inappropriate drug 1

Nalidixic Acid 9 - - 9 6 - - 6 Inappropriate drug 1

Netilmicin 5 5 - - 10 1 3 6 Not graded4

Nitrofurantoin 33 2 - 31 53 1 - 52 Inappropriate drug 1

Norfloxacin 30 19 6 5 27 19 4 4 Referee grading5

Ofloxacin 28 4 4 20 1 - - 1 Referee grading6

Oxacillin 2 - - 2 1 - - 1 Not graded2

Penicillin 3 - - 3 1 - - 1 Inappropriate drug 1

Piperacillin 12 11 - 1 25 22 2 1 87.50%

Piperacillin/Tazobactam 41 41 - - 133 114 12 7 87.43%

Polymyxin B 4 4 - - - - - - 100.00%

Quinupristin/Dalfopristin - - - - 1 - - 1 Inappropriate drug 1

Rifampin 1 - - 1 - - - - Inappropriate drug 1

Sulfisoxazole - - - - 1 - - 1 Inappropriate drug 1

Tetracycline 8 1 - 7 10 - 2 8 Inappropriate drug 1

Ticarcillin - - - - 5 5 - - 100.00%

Ticarcillin/Clavulanate 1 1 - - 6 6 - - 100.00%

Tigecycline 1 - - 1 8 1 - 7 Inappropriate drug 1

Tobramycin 18 17 - 1 38 36 1 1 95.00%

Trimethoprim - - - - 1 - - 1 Inappropriate drug 1

Trimethoprim/Sulfamethoxazole 31 1 - 30 67 1 1 65 Inappropriate drug 1

Vancomycin 1 - - 1 - - - - Inappropriate drug 1

Organism present in specimen SUS-11: Pseudomonas aeruginosa.


PARASITOLOGY (PA Specimens)

Specimen PA-11

Identification Labs Percent Performance

Entamoeba hartmanni 1 50.00% Unacceptable

No parasite seen 1 50.00% Unacceptable

Parasite present in specimen PA-11: Dientamoeba fragilis. (Graded by US consensus)

Specimen PA-12


No parasite seen 2 100% Unacceptable

Parasites present in specimen PA-12: Endolimax nana and Blastocystis hominis. (Graded by US consensus)

Specimen PA-13


Strongyloides stercoralis larvae 12 92.31% Acceptable

Hookworm 1 7.69%

Parasite present in specimen PA-13: Strongyloides stercoralis larvae.


PARASITOLOGY (PA Specimens) cont’d

Specimen PA-14


Taenia sp. eggs 12 80.00% Acceptable

Blastocystis hominis 2 13.33%

Ascaris lumbricoides eggs 1 6.67%

Parasite present in specimen PA-14: Taenia sp. eggs.

Specimen PA-15


Plasmodium ovale 3 27.27% Acceptable

Plasmodium sp., NOS 2 18.18% Acceptable

Plasmodium sp., not falciparum 1 9.09% Acceptable

Plasmodium vivax 3 27.27%

No parasite seen 2 18.18%

Parasite present in specimen PA-15: Plasmodium ovale. (Graded by US consensus)


PARASITOLOGY (FP Specimens)

Specimen FP-11


Balantidium coli 253 82.95% Acceptable

Parasite egg seen but no ID 3 0.98% Acceptable


Taenia sp. eggs 4 1.31%

Schistosoma sp. eggs, NOS 3 0.98%

Diphyllobothrium latum 3 0.98%

Endolimax nana 2 0.66%

Fasciola hepatica eggs 2 0.66%

Giardia lamblia 2 0.66%

Hookworm 2 0.66%

Paragonimus westermani eggs 2 0.66%

Schistosoma japonicum eggs 2 0.66%

Enterobius vermicularis 1 0.33%


Parasite present in specimen FP-11: Balantidium coli.


PARASITOLOGY (FP Specimens) cont’d

Specimen FP-12


Strongyloides stercoralis larvae 268 87.87% Acceptable

Parasite larva seen but no ID 2 0.66% Acceptable



Hookworm 3 0.98%

Paragonimus westermani eggs 1 0.33%

Entamoeba hartmanni 1 0.33%



Chilomastix mesnili 1 0.33%


Parasite present in specimen FP-12: Strongyloides stercoralis larvae.



Specimen FP-13


Paragonimus westermani eggs 170 56.11% Acceptable

Parasite egg seen but no ID 1 0.33% Acceptable

Fasciola hepatica eggs 47 15.51%



Strongyloides stercoralis larvae 5 1.65%

Hookworm 5 1.65%

Chilomastix mesnili 4 1.32%

Enterobius vermicularis eggs 3 0.99%

Clonorchis sinensis 3 0.99%



Schistosoma sp. eggs, NOS 2 0.66%

Trichuris trichiura eggs 1 0.33%


Entamoeba coli 1 0.33%

Parasite present in specimen FP-13: Paragonimus westermani eggs. This challenge was graded by 80% referee consensus.



Specimen FP-14


Hymenolepis nana eggs 230 48.02% Acceptable

Giardia lamblia 173 36.12% Acceptable

Other parasite seen but no ID 1 0.21%

Hymenolepis diminuta eggs 32 6.68%

Taenia sp. eggs 15 3.13%

Trichuris trichiura eggs 9 1.88%



Schistosoma japonicum eggs 2 0.42%

Hookworm 2 0.42%

Clonorchis sinensis 1 0.21%

Sarcocystis sp. oocysts 1 0.21%


Entamoeba histolytica 1 0.21%


Parasites present in specimen FP-14: Hymenolepis nana eggs and Giardia lamblia.



Specimen FP-15


No parasite seen 258 90.85% Acceptable

Trypanosoma sp., NOS 6 2.11%

Plasmodium vivax 6 2.11%

Babesia sp. 5 1.76%

Plasmodium falciparum 4 1.41%

Plasmodium sp., not falciparum 1 0.35%

Pneumocystis carinii 1 0.35%

Toxoplasma gondii 1 0.35%

Trypanosoma sp., NOS 1 0.35%

Trypanosoma cruzi 1 0.35%

Parasite present in specimen FP-15: No parasite present.


Antinuclear Antibody (ANA) - Qualitative

Specimen AE-11 Specimen AE-12 Specimen AE-13

Method Positive Negative Positive Negative Positive Negative

ALL METHODS 17 - 17 - 1 16

BioSystems 1 - 1 - - 1

Immuno Concepts 1 - 1 - - 1

INOVA Diagnostics 7 - 7 - 1 6

Kallestad 2 - 2 - - 2

Zeus 1 - 1 - - 1

Specimen AE-14 Specimen AE-15

Method Positive Negative Positive Negative

ALL METHODS 1 16 15 2

BioSystems - 1 1 -

Immuno Concepts - 1 1 -

INOVA Diagnostics 1 6 7 -

Kallestad - 2 2 -

Zeus - 1 1 -


Antinuclear Antibody (ANA)Quantitative (Titer)

This portion is not evaluated. Titers reported are as follows:

Specimen/Method

8/ 10

16/ 20

32/ 40

64/ 80

128/ 160

256/ 320

512/ 640

>640

1024/ 1280

2048/ 2560

2560

Specimen AE-11

ALL METHODS - - 1 1 1 3 2 1 2 1 -

Immuno Concepts - - 1 - - - - - - - -

INOVA Diagnostics - - - - 1 2 - 1 1 1 -

Kallestad - - - 1 - - 1 - - - -

Zeus - - - - - - - - 1 - -

Specimen AE-12

ALL METHODS - - 1 - 2 1 3 - 3 2 -

Immuno Concepts - - 1 - - - - - - - -

INOVA Diagnostics - - - - 1 1 1 - 1 2 -

Kallestad - - - - 1 - - - 1 - -

Zeus - - - - - - - - 1 - -

Specimen AE-15

ALL METHODS - - 1 1 5 1 2 - 2 - -

Immuno Concepts - - 1 - - - - - - - -

INOVA Diagnostics - - - 1 3 - - - 2 - -

Kallestad - - - - 1 1 - - - - -

Zeus - - - - - - 1 - - - -


Anti-dsDNA



ALL METHODS 1 14 15 - - 15

BioSystems - 1 1 - - 1

Diamedix - 1 1 - - 1

INOVA Diagnostics 1 5 6 - - 6

Zeus - 1 1 - - 1



ALL METHODS - 15 1 14

BioSystems - 1 - 1

Diamedix - 1 - 1

INOVA Diagnostics - 6 - 6

Zeus - 1 - 1

Anti-RNP



ALL METHODS - 8 6 2 - 8

INOVA Diagnostics - 6 5 1 - 6



ALL METHODS 1 7 - 8

INOVA Diagnostics 1 5 - 6

Specimen AE-12 is graded by 80% referee consensus.


Anti-RNP/Sm




Diamedix - 1 - 1 - 1



ALL METHODS - 6 - 6

Diamedix - 1 - 1

Anti-SSA



ALL METHODS 12 - 11 1 1 11

Diamedix 1 - 1 - - 1

INOVA Diagnostics 6 - 5 1 - 6




Diamedix - 1 - 1

INOVA Diagnostics - 6 2 4

Specimen AE-15 was graded by 82% referee consensus.


Anti-SSB



ALL METHODS 13 - 1 12 - 13

Diamedix 1 - - 1 - 1

INOVA Diagnostics 6 - 1 5 - 6



ALL METHODS - 13 - 13

Diamedix - 1 - 1


Anti-SSA/SSB



ALL METHODS 2 - 2 - 1 1



ALL METHODS - 2 1 1

Specimens AE-13 and AE-15 are graded by US consensus.


Anti-Sm




Diamedix - 1 - 1 - 1

INOVA Diagnostics - 7 5 2 - 7




Diamedix - 1 - 1


Specimen AE-12 is grade by 81% referee consensus.


RubellaQualitative

Specimen RU-11 Specimen RU-12 Specimen RU-13


ALL METHODS - 25 25 - - 25

Abbott Architect - 9 9 - - 9

bioMerieux Vidas, Mini Vidas - 2 2 - - 2

DiaSorin - 1 1 - - 1

Roche cobas 6000 / e 601 - 2 2 - - 2

Roche cobas 6000/e601 - IgG - 1 1 - - 1

Roche cobas e 411 - 4 4 - - 4

Siemens ADVIA Centaur - 1 1 - - 1

Siemens ADVIA Centaur - IgG - 3 3 - - 3

VITROS ECi - 1 1 - - 1

VITROS ECi - IgG - 1 1 - - 1

Specimen RU-14 Specimen RU-15


ALL METHODS 25 - 25 -

Abbott Architect 9 - 9 -

bioMerieux Vidas, Mini Vidas 2 - 2 -

DiaSorin 1 - 1 -

Roche cobas 6000 / e 601 2 - 2 -

Roche cobas 6000/e601 - IgG 1 - 1 -

Roche cobas e 411 4 - 4 -

Siemens ADVIA Centaur 1 - 1 -

Siemens ADVIA Centaur - IgG 3 - 3 -

VITROS ECi 1 - 1 -

VITROS ECi - IgG 1 - 1 -


RubellaQuantitative (IU/mL)

Specimen/Method

Labs

Mean

SD

CV

Median Range

Specimen RU-11

All Method 34 0.13 0.18 133.8 0.0 0.0 - 0.7

Abbott Architect 12 0.00 0.01 0.0 0.0 0.0 - 0.1

Roche cobas e 411 7 0.30 0.12 38.5 0.3 0.0 - 0.7

Specimen RU-12

All Method 35 98.75 43.79 44.3 90.0 0.0 - 230.2


Roche cobas e 411 7 140.80 12.69 9.0 137.5 102.7 - 178.9

Specimen RU-13

All Method 34 0.14 0.20 144.3 0.0 0.0 - 0.8


Roche cobas e 411 7 0.29 0.11 37.4 0.3 0.0 - 0.7

Specimen RU-14

All Method 34 26.57 11.17 42.0 25.0 0.0 - 60.1


Roche cobas e 411 7 38.60 4.28 11.1 37.7 25.7 - 51.5

Specimen RU-15

All Method 35 98.63 43.90 44.5 93.0 0.0 - 230.4


Roche cobas e 411 7 143.37 15.54 10.8 143.5 96.7 - 190.0


Syphilis SerologyQualitative: VDRL Slide

Specimen SY-11 Specimen SY-12 Specimen SY-13

Method

Reactive

Weakly Reactive

Non-Reactive

Reactive

Weakly Reactive

Non-Reactive

Reactive

Weakly Reactive

Non-Reactive

ALL METHODS 29 - 2 30 - 1 31 - -

Acon Laboratories 1 - - 1 - - 1 - -

Biokit 1 - - 1 - - 1 - -

Omega Diagnostics 1 - - 1 - - 1 - -

Plasmatec 2 - 1 3 - - 3 - -

Standard Diagnostics - - 1 - - 1 1 - -

Wiener Lab 22 - - 22 - - 22 - -

Specimen SY-14 Specimen SY-15

Method

Reactive Weakly

Reactive Non-

Reactive

Reactive Weakly

Reactive Non-

Reactive

ALL METHODS - - 31 1 - 30

Acon Laboratories - - 1 - - 1

Biokit - - 1 - - 1

Omega Diagnostics - - 1 - - 1

Plasmatec - - 3 - - 3

Standard Diagnostics - - 1 - - 1

Wiener Lab - - 22 1 - 21


Syphilis SerologyQuantitative: VDRL Slide Titer

Specimen/Method 0 dils 1 dil 2 dils 4 dils 8 dils 16 dils 32 dils >32 dils

Specimen SY-11

ALL METHODS 1 5 15 6 - 1 - -

Omega Diagnostics - - 1 - - - - -

Plasmatec - 1 - - - 1 - -

Wiener Lab 1 3 13 6 - - - -

Specimen SY-12

ALL METHODS 1 6 12 8 - - 1 -

Omega Diagnostics - - - 1 - - - -

Plasmatec - 1 - - - - 1 -

Wiener Lab 1 4 12 6 - - - -

Specimen SY-13

ALL METHODS - - 5 15 7 1 - -

Omega Diagnostics - - - 1 - - - -

Plasmatec - - 1 - - 1 - -

Wiener Lab - - 4 12 7 - - -


Syphilis SerologyQualitative: MHA-TP


Method Reactive Non-Reactive Reactive Non-Reactive Reactive Non-Reactive

ALL METHODS 14 - 14 - 14 -

Abbott Architect 4 - 4 - 4 -

Human 1 - 1 - 1 -

Omega Diagnostics 2 - 2 - 2 -

Plasmatec 1 - 1 - 1 -

Serodia 1 - 1 - 1 -


Reactive Non-Reactive Reactive Non-Reactive


Abbott Architect - 4 - 4

Human - 1 - 1

Omega Diagnostics - 2 - 2

Plasmatec - 1 - 1

Serodia - 1 - 1


Syphilis SerologyQualitative: Treponema pallidum Antibodies



ALL METHODS 36 - 35 1 36 -

Abbott Architect 3 - 3 - 3 -

bioMerieux 1 - 1 - 1 -

Human 1 - 1 - 1 -

Omega Diagnostics 4 - 3 1 4 -

Plasmatec 2 - 2 - 2 -

Roche cobas 6000 / c 501 1 - 1 - 1 -

Serodia 13 - 13 - 13 -

SPINREACT 1 - 1 - 1 -




Abbott Architect - 3 - 3

bioMerieux - 1 - 1

Human - 1 - 1


Plasmatec - 2 - 2

Roche cobas 6000 / c 501 - 1 - 1

Serodia - 13 - 13

SPINREACT - 1 - 1


Syphilis SerologyQualitative: RPR



ALL METHODS 104 1 102 3 105 -

ASI 2 - 2 - 2 -

Becton Dickinson 3 - 3 - 3 -

Biokit 2 - 2 - 2 -

bioMerieux 7 - 7 - 7 -

BioSystems 12 - 12 - 12 -

Human 10 - 10 - 10 -

Immunostics Inc. 2 - 2 - 2 -

Omega Diagnostics 17 - 17 - 17 -

Plasmatec 12 - 12 - 12 -

Pulse Scientific 1 - 1 - 1 -

SPINREACT 19 - 19 - 19 -

Standard Diagnostics 1 1 1 1 2 -

Wampole Impact RPR 3 - 3 - 3 -

Wiener Lab 1 - 1 - 1 -




ASI - 2 - 2

Becton Dickinson - 3 - 3

Biokit - 2 - 2

bioMerieux - 7 - 7

BioSystems - 11 - 11

Human - 10 - 10

Immunostics Inc. - 2 - 2


Plasmatec - 12 - 12

Pulse Scientific - 1 - 1

SPINREACT - 19 - 19

Standard Diagnostics - 2 - 2

Wampole Impact RPR - 3 - 3

Wiener Lab - 1 - 1


Syphilis SerologyQuantitative: RPR (Titer)

Specimen/Method 1 2 4 8 16 32 64 >64

Specimen SY-11

ALL METHODS 20 34 12 1 1 1 - -

Becton Dickinson - 1 1 - - - - -

bioMerieux 2 3 - - - - - -

BioSystems 2 5 2 - - - - -

Human 5 1 1 - - - - -

Immunostics Inc. 1 - - - - - - -

Omega Diagnostics 2 7 2 - - 1 - -

Plasmatec 6 2 1 - 1 - - -

SPINREACT - 11 2 1 - - - -

Wampole Impact RPR - 1 - - - - - -

Wiener Lab - - 1 - - - - -

Specimen SY-12

ALL METHODS 14 37 14 2 2 1 - -

Becton Dickinson - - 2 - - - - -

bioMerieux 2 2 1 - - - - -

BioSystems 1 6 3 - - - - -

Human 3 3 1 - - - - -

Immunostics Inc. 1 - - - - - - -

Omega Diagnostics 2 7 1 1 1 - - -

Plasmatec 4 4 1 - - 1 - -

SPINREACT - 10 3 - 1 - - -


Wiener Lab - 1 - - - - - -


Syphilis SerologyQuantitative: RPR (Titer) cont’d

Specimen/Method 1 2 4 8 16 32 64 >64

Specimen SY-13

ALL METHODS 2 17 34 13 2 1 - 1

Becton Dickinson - - - 2 - - - -

bioMerieux - 1 3 1 - - - -

BioSystems - 3 4 3 - - - -

Human - 4 2 1 - - - -

Immunostics Inc. - 1 - - - - - -

Omega Diagnostics - 2 7 1 - 1 - 1

Plasmatec 2 3 4 - 1 - - -

SPINREACT - 1 8 4 1 - - -


Wiener Lab - - 1 - - - - -


Viral Markers – Anti-HBc (IgM)

Specimen VM-11 Specimen VM-12 Specimen VM-13

Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 1 73 - 53 20 1 4 70 -

Abbott Architect - 30 - 28 1 1 - 30 -

Beckman ACCESS / 2 / DxI - 2 - 2 - - - 2 -

Bio-Rad Evolis - 1 - 1 - - 1 - - bioMerieux Vidas, Mini Vidas - 6 - 6 - - - 6 -

Roche cobas 6000 / e 601 1 10 - 2 9 - 2 9 -

Roche cobas e 411 - 3 - - 3 - - 3 -

Roche Elecsys 1010 / 2010 - 1 - - 1 - - 1 -

Roche Modular Analytics - 1 - - 1 - - 1 -

Siemens ADVIA Centaur - 10 - 10 - - - 10 -

VITROS 3600/4600/5600 - 3 - - 3 - - 3 -

Specimen VM-14 Specimen VM-15

Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 4 69 1 1 72 -

Abbott Architect - 30 - - 30 -

Beckman ACCESS / 2 / DxI - 2 - - 2 -

Bio-Rad Evolis 1 - - - 1 -

bioMerieux Vidas, Mini Vidas - 6 - - 6 -

Roche cobas 6000 / e 601 2 9 - - 10 -

Roche cobas e 411 - 3 - - 3 -

Roche Elecsys 1010 / 2010 - 1 - - 1 -

Roche Modular Analytics - 1 - - 1 -

Siemens ADVIA Centaur - 10 - - 10 -

VITROS 3600/4600/5600 - 2 1 - 3 -


Viral Markers – Anti-HBc (Total / IgG)


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 10 84 - 92 2 - 93 1 -

Abbott Architect 1 40 - 41 - - 41 - -

Abbott Architect - Total - 1 - 1 - - 1 - -

Beckman ACCESS / 2 / DxI 2 - - 2 - - 2 - - bioMerieux Vidas, Mini Vidas - 5 - 4 1 - 5 - -

DiaSorin - 1 - 1 - - 1 - -

Roche cobas 6000 / e 601 3 8 - 11 - - 11 - -

Roche cobas e 411 4 4 - 8 - - 8 - -

Roche Modular Analytics - 4 - 4 - - 4 - -

Siemens ADVIA Centaur - 14 - 14 - - 14 - -

VITROS 3600/4600/5600 - 2 - 2 - - 2 - -


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 89 4 - 3 90 -

Abbott Architect 41 - - - 41 -

Abbott Architect - Total 1 - - - 1 -

Beckman ACCESS / 2 / DxI 2 - - - 2 -

bioMerieux Vidas, Mini Vidas 4 1 - - 5 -

DiaSorin 1 - - - 1 -

Roche cobas 6000 / e 601 10 1 - - 10 -

Roche cobas e 411 7 1 - 1 7 -

Roche Modular Analytics 4 - - - 4 -

Siemens ADVIA Centaur 13 - - - 14 -

VITROS 3600/4600/5600 2 - - - 2 -


Viral Markers – Anti-HIV


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 2 258 - - 260 - 260 - -

Abbott Architect - 74 - - 74 - 74 - -

Abbott Architect - Total - 1 - - 1 - 1 - - Alere Determine HIV 1/2 Ag/Ab Combo - 2 - - 2 - 2 - -

Beckman ACCESS / 2 / DxI - 10 - - 10 - 10 - -

Bio-Rad Evolis - 1 - - 1 - 1 - - bioMerieux Vidas, Mini Vidas - 12 - - 12 - 12 - -

DiaSorin - 1 - - 1 - 1 - -

Human - 1 - - 1 - 1 - -

Roche cobas 6000 / e 601 1 43 - - 44 - 44 - -

Roche cobas e 411 1 26 - - 27 - 27 - -

Roche Elecsys - Total - 1 - - 1 - 1 - -

Roche Elecsys 1010 / 2010 - 3 - - 3 - 3 - -

Roche Modular Analytics - 7 - - 7 - 7 - -

Siemens ADVIA Centaur - 48 - - 48 - 48 - -

Standard Diagnostics - 3 - - 3 - 3 - -

VITROS 3600/4600/5600 - 4 - - 4 - 4 - -

VITROS ECi - 4 - - 4 - 4 - -


Viral Markers – Anti-HIV- cont’d


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 5 252 1 76 171 12


Abbott Architect - Total - 1 - - 1 -

Alere Determine HIV 1/2 Ag/Ab Combo - 2 - - 2 -

Beckman ACCESS / 2 / DxI 1 9 - 2 8 -

Bio-Rad Evolis - 1 - - 1 -

bioMerieux Vidas, Mini Vidas - 12 - 8 3 1

DiaSorin - 1 - 1 - -

Human - 1 - - 1 -

Roche cobas 6000 / e 601 1 43 - 31 10 2

Roche cobas e 411 1 25 1 21 3 3

Roche Elecsys - Total - 1 - - - 1

Roche Elecsys 1010 / 2010 1 2 - 3 - -

Roche Modular Analytics - 7 - 6 1 -

Siemens ADVIA Centaur 1 46 - 1 45 2

Standard Diagnostics - 3 - - 3 -

VITROS 3600/4600/5600 - 4 - - 4 -

VITROS ECi - 4 - - 4 -

Specimen VM-15 was graded by 83% referee consensus.


Viral Markers – Anti-HAV (IgM)


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 96 2 1 1 98 - 1 98 -

Abbott Architect 34 1 1 1 35 - - 36 -

Beckman ACCESS / 2 / DxI 1 - - - 1 - - 1 - bioMerieux Vidas, Mini Vidas 11 - - - 11 - - 11 -

Roche cobas 6000 / e 601 13 1 - - 14 - - 14 -

Roche cobas e 411 8 - - - 8 - 1 7 -

Roche Modular Analytics 5 - - - 5 - - 5 -

Siemens ADVIA Centaur 17 - - - 17 - - 17 -

Standard Diagnostics 1 - - - 1 - - 1 -

VITROS 3600/4600/5600 1 - - - 1 - - 1 -

VITROS ECi 1 - - - 1 - - 1 -


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 3 95 - 2 96 -

Abbott Architect 1 35 - - 36 -

Beckman ACCESS / 2 / DxI - 1 - - 1 -


Roche cobas 6000 / e 601 1 13 - 1 12 -

Roche cobas e 411 1 7 - 1 7 -




VITROS 3600/4600/5600 - 1 - - 1 -



Viral Markers – Anti-HAV (Total/IgG)


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 98 - - 3 95 - 97 1 -

Abbott Architect 36 - - - 36 - 36 - -

Beckman ACCESS / 2 / DxI 1 - - - 1 - 1 - - bioMerieux Vidas, Mini Vidas 8 - - - 8 - 8 - -

Roche cobas 6000 / e 601 12 - - 1 11 - 12 - -

Roche cobas e 411 7 - - 1 6 - 7 - -

Roche Elecsys 1010 / 2010 2 - - - 2 - 2 - -

Roche Modular Analytics 2 - - - 2 - 2 - -

Siemens ADVIA Centaur 21 - - 1 20 - 21 - -

Standard Diagnostics 1 - - - 1 - - 1 -

VITROS ECi 1 - - - 1 - 1 - -


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 96 1 - 65 29 4

Abbott Architect 36 - - 30 5 1


bioMerieux Vidas, Mini Vidas 8 - - 4 2 2

Roche cobas 6000 / e 601 12 - - 12 - -

Roche cobas e 411 7 - - 7 - -

Roche Elecsys 1010 / 2010 2 - - 2 - -

Roche Modular Analytics 2 - - 2 - -

Siemens ADVIA Centaur 20 - - 3 18 -


VITROS ECi 1 - - 1 - -


Viral Markers – HBeAg


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS - 63 - - 63 - - 63 -

Abbott Architect - 23 - - 23 - - 23 - bioMerieux Vidas, Mini Vidas - 4 - - 4 - - 4 -

DiaSorin - 2 - - 2 - - 2 -

Roche cobas 6000 / e 601 - 10 - - 10 - - 10 -

Roche cobas e 411 - 4 - - 4 - - 4 -

Roche Elecsys 1010 / 2010 - 1 - - 1 - - 1 -


Siemens ADVIA Centaur - 11 - - 11 - - 11 -

VITROS ECi - 1 - - 1 - - 1 -


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 28 34 - 1 62 -




Roche cobas 6000 / e 601 10 - - 1 9 -

Roche cobas e 411 2 2 - - 4 -

Roche Elecsys 1010 / 2010 1 - - - 1 -

Roche Modular Analytics 2 1 - - 3 -

Siemens ADVIA Centaur 9 1 - - 11 -



Viral Markers – Anti-HBs


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS - 190 - - 190 - 189 1 -

Abbott Architect - 60 - - 60 - 60 - -

Beckman ACCESS / 2 / DxI - 3 - - 3 - 3 - - bioMerieux Vidas, Mini Vidas - 6 - - 6 - 6 - -

Roche cobas 6000 / e 601 - 34 - - 34 - 33 1 -

Roche cobas e 411 - 20 - - 20 - 20 - -

Roche Elecsys 1010 / 2010 - 2 - - 2 - 2 - -

Roche Modular Analytics - 6 - - 6 - 6 - -

Siemens ADVIA Centaur - 44 - - 44 - 44 - -

VITROS 3600/4600/5600 - 4 - - 4 - 4 - -

VITROS ECi - 2 - - 2 - 2 - -


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 2 187 - 9 179 2

Abbott Architect - 60 - 3 57 -

Beckman ACCESS / 2 / DxI 1 2 - - 2 1


Roche cobas 6000 / e 601 1 33 - 2 31 1

Roche cobas e 411 - 20 - 1 19 -

Roche Elecsys 1010 / 2010 - 2 - 1 1 -



VITROS 3600/4600/5600 - 4 - - 4 -



Viral Markers – HBsAg


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 58 197 7 247 14 1 1 261 -

Abbott Architect - 74 - 74 - - 1 73 -

Abbott Architect - Total - 1 - 1 - - - 1 -

Beckman ACCESS / 2 / DxI - 8 - 7 1 - - 8 -

Bio-Rad Evolis - 1 - 1 - - - 1 -

bioMerieux Vidas, Mini Vidas 1 9 - 9 1 - - 10 -

DiaSorin - 1 - 1 - - - 1 -

Roche cobas 6000 / e 601 29 6 3 37 1 - - 38 -

Roche cobas e 411 18 12 3 33 - - - 33 -

Roche Elecsys - Total - 1 - 1 - - - 1 -

Roche Elecsys 1010 / 2010 1 3 - 4 - - - 4 -

Roche Modular Analytics 5 2 - 7 - - - 7 -

Siemens ADVIA Centaur 1 47 - 46 1 1 - 48 -

Standard Diagnostics - 3 - - 3 - - 3 -

VITROS 3600/4600/5600 1 4 - 5 - - - 5 -

VITROS ECi - 6 - 6 - - - 6 -

Specimen VM-11 was graded by 91% referee consensus.


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 258 1 1 38 213 11

Abbott Architect 73 1 - 2 72 -

Abbott Architect - Total 1 - - - 1 -


Bio-Rad Evolis 1 - - - 1 -

bioMerieux Vidas, Mini Vidas 10 - - 1 9 -


Roche cobas 6000 / e 601 38 - - 18 13 7

Roche cobas e 411 33 - - 10 21 2

Roche Elecsys - Total 1 - - - 1 -

Roche Elecsys 1010 / 2010 4 - - - 4 -

Roche Modular Analytics 7 - - 3 3 1

Siemens ADVIA Centaur 46 - 1 2 46 -

Standard Diagnostics 3 - - - 3 -

VITROS 3600/4600/5600 5 - - - 5 -

VITROS ECi 6 - - - 6 -


Viral Markers – Anti-HCV


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 1 226 - 1 226 - 1 226 -

Abbott Architect 1 71 - - 72 - - 72 -

Abbott Architect - Total - 1 - - 1 - - 1 -

Beckman ACCESS / 2 / DxI - 5 - - 5 - - 5 -

Bio-Rad Evolis - 1 - - 1 - - 1 -

bioMerieux Vidas, Mini Vidas - 6 - - 6 - - 6 -

DiaSorin - 1 - - 1 - - 1 -

Roche cobas 6000 / e 601 - 30 - - 30 - - 30 -

Roche cobas e 411 - 24 - - 24 - 1 23 -

Roche Elecsys 1010 / 2010 - 3 - - 3 - - 3 -


Siemens ADVIA Centaur - 45 - - 45 - - 45 -

Standard Diagnostics - 4 - - 4 - - 4 -

VITROS 3600/4600/5600 - 5 - 1 4 - - 5 -

VITROS ECi - 6 - - 6 - - 6 -


Method

Positive

Negative

Equivocal

Positive

Negative

Equivocal

ALL METHODS 62 162 1 226 1 -

Abbott Architect 1 71 - 71 1 -

Abbott Architect - Total - 1 - 1 - -

Beckman ACCESS / 2 / DxI - 5 - 5 - -

Bio-Rad Evolis - 1 - 1 - -

bioMerieux Vidas, Mini Vidas - 6 - 6 - -

DiaSorin - 1 - 1 - -

Roche cobas 6000 / e 601 28 2 - 30 - -

Roche cobas e 411 21 3 - 24 - -

Roche Elecsys 1010 / 2010 3 - - 3 - -

Roche Modular Analytics 6 - - 6 - -

Siemens ADVIA Centaur 1 43 - 45 - -

Standard Diagnostics - 4 - 4 - -

VITROS 3600/4600/5600 - 5 - 5 - -

VITROS ECi - 6 - 6 - -

72 /2015 MLE-M3 Participant Summary

Toxoplasma gondii Antibody (IgG) - Qualitative

Specimen TOX-5 Specimen TOX-6


ALL METHODS 29 - - 29

Abbott Architect 10 - - 10

Beckman ACCESS / 2 / DxI 3 - - 3

bioMerieux Vidas, Mini Vidas 3 - - 3

DiaSorin 1 - - 1 Roche cobas 6000 / e 601 2 - - 2 Roche cobas e 411 5 - - 5 Roche Elecsys 1010 / 2010 1 - - 1 Siemens ADVIA Centaur 3 - - 3 VITROS ECi 1 - - 1

Toxoplasma gondii Antibody (IgG) Quantitative (IU/mL)

Specimen/Method

Labs

Mean

SD

CV

Median Range

Specimen TOX-5

All Method 30 490.230 244.723 49.9 462.00 0.78 - 979.68


Roche cobas e 411 6 553.567 128.562 23.2 619.30 296.44 - 810.70

Specimen TOX-6

All Method 28 0.095 0.088 92.2 0.10 0.00 - 0.28


Roche cobas e 411 6 0.193 0.103 53.0 0.13 0.00 - 0.40


Toxoplasma gondii Antibody (IgM) - Qualitative

Specimen TOX-5 Specimen TOX-6


ALL METHODS 28 - 1 27

Abbott Architect 8 - - 8

Beckman ACCESS / 2 / DxI 3 - 1 2


DiaSorin 1 - - 1 Roche cobas 6000 / e 601 4 - - 4 Roche cobas e 411 4 - - 4 Roche Elecsys 1010 / 2010 1 - - 1 Siemens ADVIA Centaur 3 - - 3 VITROS ECi 1 - - 1

Toxoplasma gondii Antibody (IgM) Quantitative (IU/mL)

Specimen/Method

Labs

Mean

SD

CV

Median Range

Specimen TOX-5

All Method 23 15.382 15.763 102.5 7.23 0.00 - 46.91


Specimen TOX-6

All Method 23 0.174 0.096 55.0 0.18 0.00 - 0.37



Cytomegalovirus (CMV) Antibodies (IgG) - Qualitative

Specimen CMV-5 Specimen CMV-6


ALL METHODS 20 1 12 9

Abbott Architect 10 - 10 -

Beckman ACCESS / 2 / DxI 1 - - 1


DiaSorin 1 - 1 -

Roche cobas 6000 / e 601 1 - - 1

Roche cobas e 411 3 1 1 3

VITROS ECi 1 - - 1

Cytomegalovirus (CMV) Antibodies (IgG) Quantitative (U/mL)

Specimen/Method

Labs

Mean

SD

CV

Median Range

Specimen CMV-5

All Method 21 99.791 36.081 36.2 96.30 27.62 - 171.96


Specimen CMV-6

All Method 21 7.714 7.029 91.1 4.00 0.00 - 21.78



Cytomegalovirus (CMV) Antibodies (IgM) - Qualitative

Specimen CMV-5 Specimen CMV-6



Abbott Architect - 8 8 -

Beckman ACCESS / 2 / DxI - 1 1 -

bioMerieux Vidas, Mini Vidas - 3 3 -

DiaSorin - 1 1 -

DPC Immulite 2000 - 1 1 -

Roche cobas 6000 / e 601 - 2 - 2

Roche cobas e 411 - 4 - 4

VITROS ECi - 1 1 -

Cytomegalovirus (CMV) Antibodies (IgM) Quantitative (U/mL)

Specimen/Method

Labs

Mean

SD

CV

Median Range

Specimen CMV-5

All Method 19 0.178 0.146 82.2 0.17 0.00 - 0.48


Specimen CMV-6

All Method 19 2.249 1.448 64.4 2.53 0.00 - 5.15



Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700

Washington, DC 20001-7401

800-338-2746 202-261-4500 Fax: 202-835-0440 www.acponline.org/mle

CK-MB - Quantitative (U/L)

Specimen/Method

Labs

Mean

SD

CV

Median Range

Specimen CK-11

All Method 12 99.80 29.88 29.9 88.1 10.1 - 189.5

Roche cobas 6000 / c 501 7 87.39 2.34 2.7 87.4 80.3 - 94.5

Specimen CK-12

All Method 11 17.82 2.08 11.6 17.1 11.5 - 24.1

Roche cobas 6000 / c 501 7 17.44 1.00 5.7 17.1 14.4 - 20.5

Specimen CK-13

All Method 13 37.51 22.66 60.4 28.0 0.0 - 105.5

Roche cobas 6000 / c 501 7 28.01 1.61 5.8 27.8 23.1 - 32.9

Specimen CK-14

All Method 12 54.53 17.36 31.8 48.2 2.4 - 106.7

Roche cobas 6000 / c 501 7 47.73 1.58 3.3 48.0 43.0 - 52.5

Specimen CK-15

All Method 12 8.88 3.38 38.0 7.9 0.0 - 19.1

Roche cobas 6000 / c 501 7 7.83 0.48 6.1 8.0 6.3 - 9.3

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